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Objectives: The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions. Background: Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials. Methods: The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES. Results: The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non–Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar. Conclusions: After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269) [Copyright &y& Elsevier]

Objectives: The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial. Background: Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined. Methods: Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES. Results: Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups. Conclusions: One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions. [Copyright &y& Elsevier]

The article presents a study on sidebranch occlusion during zotarolimus-eluting stent (ZES) and paclitaxel-eluting stent (PES) in relation to the periprocedural myocardial infarction (MI) incidences. Frequency of sidebranch occlusion-related MI in 1,216 ZES or PES treated patients were assessed. It is found that ZES treated patients have lower risk of sidebranch occlusion during stent placement than those treated with PES which may have helped lessen periprocedural MI in the study.

An abstract of the article "Measuring Extrinsic and Intrinsic Hand Strength in Healthy Adults: Inter-Rater Reliability of the Rotterdam Intrinsic Hand Myometer," by Corey McGee and colleagues is presented.

Background: The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS)., Methods and Results: Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES., Conclusions: These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.

Background: A novel antisense phosphorodiamidate morpholino oligomer, AVI-4126, was shown to be effective in reducing neointimal formation in different animal models following delivery by pluronic gels, porous balloon catheters, and coated stents. The purpose of the AVAIL study was to investigate both the safety and the efficacy of AVI-4126 delivered locally via Infiltrator catheter after percutaneous coronary intervention in humans., Methods: The AVAIL trial is a prospective, evaluator-blinded, randomized study including clinical follow-up at 30 days and 6 months after intervention and 6-month angiographic and intravascular ultrasound (IVUS) follow-up. An Infiltrator catheter was advanced to target lesion and either drug was delivered (Groups A and B) or catheter was advanced (Group C) after stent implantation in de novo lesions or percutaneous transluminal coronary angioplasty in restenotic lesions. Primary end points include major adverse cardiovascular events (MACE), target vessel revascularization (TVR), angiographic restenosis, and IVUS at 6 months., Results: Forty-four patients with either de novo lesions or restenosis were randomized into three groups: (A) low dose, 3 mg (19 patients); (B) high dose, 10 mg (15 patients), and (C) control (10 patients). Baseline angiographic characteristics did not differ between the groups (reference vessel diameter, 2.5-4 mm; lesion length, <16 mm). Procedural success was 81. 82% (unable to advance Infiltrator catheter to target lesion in 8 patients, 5 from Group B and 3 from Group C). There was no in-hospital or 30-day MACE recorded in any group. Clinical follow-up was available in 25 patients. At 6 months, four patients (50%) from the control group (Group C, n=8) and 7 (100%) patients from the low-dose group (Group A, n=7) required TVR. In contrast, in the high-dose group (Group B, n=10) only 1 patient (10%) needed TVR. Angiographic follow-up in 25 patients (Group A, 8 patients; Group B, 7 patients; and Group C, 10 patients) demonstrated late loss of 1.4+ to 0.54, 0.8+ to 0.55, and 1.5+ to 0.65, respectively (P=.025). Binary restenosis was 38% in Group C (control), 29% in Group A (low dose), and 0% in Group B (high dose)., Conclusion: Local delivery of antisense is feasible. These preliminary findings from the small cohort of patients require confirmation in a larger trial utilizing more sophisticated drug-eluting technologies.

Up to 10% of patients who arrive at the hospital with acute myocardial infarction (AMI) present with or develop cardiogenic shock. Some patients, despite inotropes and intra-aortic balloon pump (IABP) placement, are not hemodynamically stable enough to undergo emergent revascularization. The use of percutaneous extracorporeal life support (ECLS) can stabilize patients to allow effective therapy. In a retrospective review of the first 100 patients emergently placed on ECLS by a nurse-supported physician insertion technique at Sharp Memorial Hospital, 10 patients underwent placement of ECLS after out-of hospital AMI. All AMI patients required intubation for respiratory failure and temporary CPR for cardiovascular collapse before initiation of ECLS. Of the 10 AMI patients placed on ECLS, four (40%) are currently long-term survivors (5.1 +/- 4.2 years; range, 6 months to 11 years). All survivors underwent successful revascularization after placement on ECLS. The cause of death in the other six patients was neurologic insufficiency in two, ineffective ECLS in two, and recurrent cardiovascular collapse after weaning from bypass in two. Total CPR time before initiation of cardiopulmonary bypass was 17 +/- 10.3 minutes for the survivors and 54.2 +/-11.1 minutes for the nonsurvivors (p < 0.001). The average time on ECLS was 29 +/- 26 hours for the survivors and 30 +/-67 hours for the nonsurvivors (p = NS). Leg complications were common among long-term survivors, associated with the use of ECLS (three ischemia, one infection). After AMI and cardiovascular collapse, insertion of ECLS may permit long-term patient survival.

Background: Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in approximately 20% of patients during this time period. Routine (primary) stent implantation after PTCA has the potential to further improve late outcomes., Methods and Results: Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers. A mean of 1.4+/-0.7 stents were implanted per patient (97% Palmaz-Schatz) at 17.3+/-2.4 atm. During a clinical follow-up period of 7.4+/-2.6 months, death occurred in 4 patients (1.7%), reinfarction occurred in 5 patients (2.1%), and TVR was required in 26 patients (11.1%). By Cox regression analysis, small reference-vessel diameter and the number of stents implanted were the strongest determinants of TVR. Angiographic restenosis occurred in 27.5% of lesions. By multiple logistic regression analysis, the number of stents implanted and the absence of thrombus on the baseline angiogram were independent determinants of binary restenosis., Conclusions: A strategy of routine stent implantation during mechanical reperfusion of AMI is safe and is associated with favorable event-free survival and low rates of restenosis compared with primary PTCA alone.

Objectives: The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI)., Background: Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion., Methods: Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length < or = 2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen., Results: Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%)., Conclusions: Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.

In the New Approaches to Coronary Intervention (NACI) registry, 887 patients were electively treated with excimer laser coronary angioplasty (ELCA) for coronary artery disease. The Advanced Interventional System (AIS) system was used in 487 cases; the Spectranetics system, in 400. The mean age was 63.4 years. Most patients had unstable angina (60.3%); 43.7% had a prior myocardial infarction; and 18.6% were high risk or inoperable patients. Mean ejection fraction was 55.4%. A total of 1,000 lesions were treated in the 887 patients. Of the 1,000 lesions treated with ELCA in the 887 patients, 36% were in the right coronary artery; 33%, left anterior descending; 13%, circumflex; 3%, left main; and 16.6%, vein graft. By angiographic core laboratory analysis available for 752 (85%) patients with 839 lesions, lesions were 12.76 mm long. The minimum lumen diameter increased to 1.29 mm after the laser and finally to 1.95 mm after adjunctive percutaneous transluminal coronary angioplasty (PTCA) (which was performed in 93% of all lesions), with a final residual stenosis of 32.1% and Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in 95%. Dissections of grades B, C, or D were seen after 22.0% of initial laser attempts, and postlaser perforations were noted in 2.6%. Additional such dissections accumulated after adjunctive PTCA but the perforation rate remained low. Procedural success was achieved in 84% of patients, but 1.2% died, 0.7% experienced Q-wave myocardial infarction (MI), and 2.7% required emergency bypass surgery. Multiple logistic regression analysis could not identify any independent predictors of these in-hospital complications. One-year mortality was 5.7% and the cumulative incidence of Q-wave MI was 1.5%. Coronary artery bypass graft (CABG) surgery was performed in 15.0% of patients whereas 25.5% required repeat percutaneous intervention with a target lesion revascularization rate of 31%. Independent predictors of death, Q-wave MI, or target lesion revascularization (which, combined, occurred in 35.6% of patients) were the absence of prior MI, ELCA in the circumflex, perforation after the procedure, and small (<2 mm) final minimal lumen diameter. Considering the large number of patients with high-risk lesions, laser angioplasty was performed with excellent procedural success rates and a reasonable incidence of major complications.

Background: Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts., Methods: A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later., Results: As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (+/-SD) increase in luminal diameter immediately after the procedure (1.92+/-0.30 mm, as compared with 1.21+/-0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85+/-0.96 vs. 0.54+/-0.91 mm, P=0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P=0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03)., Conclusions: As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy. In the Primary Angioplasty in Myocardial Infarction (PAMI) trial, 395 patients with acute myocardial infarction were randomized to tissue plasminogen activator (t-PA) or primary PTCA. Conditions were present in 151 patients (38%) which formerly would have contraindicated thrombolytic therapy (age > 70 yr, symptom duration > 4 hr, or prior bypass surgery). In-hospital mortality was 4.3-fold higher in patients with former thrombolytic contraindications compared to lytic-eligible patients (8.6% vs. 2.0%, P = .002). Lytic-eligible patients treated with t-PA and PTCA had similar in-hospital mortality (1.7% vs. 2.4%, P = NS). In contrast, both in-hospital (2.9% vs. 13.2%, P = .025) and 6-mo mortality (2.9% vs. 15.7%, P = .009) were significantly reduced in patients with former thrombolytic contraindications treated by primary PTCA compared to t-PA. By logistic regression analysis, treatment by PTCA rather than t-PA was the strongest predictor of survival in patients with former thrombolytic contraindications. We conclude that patients with conditions formerly contraindicating thrombolytic therapy constitute a high-risk group with significant morbidity and mortality after lytic reperfusion. Our data suggest that patients with former contraindications to thrombolytic therapy may benefit by preferential management with primary PTCA without antecedent thrombolysis.

At 12 centers, 395 patients, including 288 men (73%) and 107 women (27%) with acute myocardial infarction (AMI), were prospectively randomized to treatment with tissue plasminogen activator (t-PA) or primary percutaneous transluminal coronary angioplasty (PTCA). Compared with men, women were older (65.7 vs 57.7 years, p < 0.0001), more often had diabetes mellitus (19% vs 10%, p = 0.03), systemic hypertension (54% vs 39%, p = 0.005), prior congestive heart failure (5% vs 0%, p = 0.002), and presented later after symptom onset (229 vs 174 minutes, p = 0.0004). The in-hospital mortality in women was 3.3-fold higher than men (9.3% vs 2.8%, p = 0.005). After adjustment for comorbid baseline characteristics, however, only advanced age independently correlated with mortality. Among t-PA-treated patients, mortality was significantly higher in women than in men (14.0% vs 3.5%, p = 0.006). Intracranial hemorrhage after t-PA was also more common in women than in men (5.3% vs 0.7%, p = 0.037). In contrast, women and men had similar in-hospital mortality after primary PTCA (4.0% vs 2.1%, respectively, p = 0.46). No intracranial bleeding occurred in PTCA-treated patients. A univariate trend was present for reduced in-hospital mortality in women treated with PTCA rather than t-PA (4.0% vs 14.0%, p = 0.07). By multiple logistic regression analysis of 15 clinical variables, treatment with PTCA rather than t-PA, as well as younger age, were independently predictive of in-hospital survival in women.(ABSTRACT TRUNCATED AT 250 WORDS)

More than 2,000 angioplasties have been performed in our institutions either during or surrounding acute myocardial infarction. We will review the practical aspects of the performance of primary percutaneous transluminal coronary angioplasty with outlines for implementation of the angiogram, conducting angioplasty, giving adjunctive therapies, care of the patient after the intervention and the potential need for subsequent coronary bypass surgery. The rationale for risk stratification with angiography, order and technical aspects of the performance of percutaneous transluminal coronary angioplasty, need for adjunctive medical therapy and details of after care will be fundamentally outlined.

Since beginning primary angioplasty in the early eighties we have used angioplasty in or related to acute myocardial infarction in over 2,300 patients. We will review here the use of direct, immediate, rescue and deferred or elective angioplasty in acute myocardial infarction. Organization of the cardiac catheterization laboratory staff, transport programs, and planning for surgical stand-by have all contributed to patient benefit in our program and will be outlined. Our acute MI approach both for angioplasty and for follow-up surgery will be reviewed.

Emergency cardiopulmonary support has been used in the United States since 1986, mainly by physicians at participating centers for the National Registry of Elective Supported Angioplasty. Data from the National Registry as well as the experience in three institutions from a number of operators were analyzed to assess the benefits of the emergency cardiopulmonary support application in patients with hemodynamic collapse. Patients who had experienced either cardiac arrest or hemodynamic collapse with cardiogenic shock unresponsive to pressors were placed emergently on cardiopulmonary support. They were either then treated with angioplasty or with revascularization surgery. Patients placed on cardiopulmonary support in less than 15 min experienced a 48% survival rate across the whole registry of the participating centers of the National Cardiopulmonary Bypass Registry. A two-center experience has demonstrated a 69% survival rate. Patients treated with emergency cardiopulmonary support who have experienced hemodynamic collapse have improved survivorship over any other hemodynamic support system. With increasing experience by the operators, the results have improved for survivorship, particularly in the early application group.